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Competitive Landscape
What MAUDE Can and Can't Tell You
Before diving into the data, understand what this analysis can and cannot do.
MAUDE CAN tell you:
- Failure patterns -- are the same mechanical issues repeating?
- Injury rates per event -- what % of reports involve patient harm?
- Temporal trends -- are failures accelerating, stable, or spiking?
- Attribution patterns -- is the manufacturer blaming users for design issues?
- Failure mode distribution -- mechanical vs. sterility vs. material
MAUDE CANNOT tell you:
- Absolute safety -- more events often means more market share, not worse safety
- Real complication rates -- only 1-10% of actual events get reported
- Precise market share -- no public source gives exact manufacturer share
- Head-to-head comparison by volume -- without knowing devices in field, raw counts are misleading
The Midline Market: Five Players
Every major midline catheter on the US market uses a guidewire for insertion -- except Stiletto. This is the structural fact that defines the competitive landscape.
| Manufacturer | Product | Share (est.) | Insertion | Guidewire | Differentiator |
|---|---|---|---|---|---|
| BD | PowerGlide Pro | ~40% | 5-step modified Seldinger | Yes | Market leader, distribution scale |
| ICU Medical | PowerWand | ~15% | Accelerated Seldinger (AST) | Yes | BIOGUARD antimicrobial coating |
| Teleflex | Arrow Midline | ~10% | Modified Seldinger | Yes | Arrowg+ard Blue antimicrobial |
| AngioDynamics | BioFlo Midline | ~8% | Guidewire-assisted | Yes | Endexo anti-thrombotic technology |
| Avia Vascular | Stiletto | <5% | 2-step SlipStream | No | Only guidewire-free midline |
Two innovation stories are playing out in this market:
- Coating chemistry (ICU Medical, Teleflex, AngioDynamics) -- reduce infection or thrombosis after insertion
- Engineering simplicity (Stiletto) -- eliminate the failure mechanism during insertion
Both are valid. But only one addresses the 90% mechanical failure pattern in MAUDE data.
#1: BD PowerGlide Pro (~40% Share)
The incumbent. The device Stiletto must displace.
MAUDE Profile
| Product | Events | Injuries | Injury Rate | Deaths |
|---|---|---|---|---|
| PowerGlide Pro | 26 | 20 | 76.9% | 0 |
| PowerLoc | 14 | 11 | 78.6% | 0 |
| PowerGlide Midline | 14 | 10 | 71.4% | 0 |
| PowerMidline | 13 | 7 | 53.8% | 0 |
| PowerPICC SOLO2, 3CG | 40 | 5 | 12.5% | 0 |
| PowerPICC SOLO2 | 27 | 5 | 18.5% | 0 |
| PowerPICC 3CG | 19 | 2 | 10.5% | 0 |
The pattern: BD's midline/PowerGlide products have 4-7x the injury rate of their own PICC products. Same manufacturer, same quality systems -- the difference is the insertion mechanism. Midlines use the guidewire-at-bevel design; PICCs don't.
Failure Modes (n=90 extracted)
90% mechanical. Not random. Not manufacturing variation. A consistent pattern pointing at the guidewire-catheter interaction:
- Catheter fracture at needle bevel (chevron break pattern)
- Guidewire kinking during insertion
- Guidewire knotting
- Tip separation or shearing
- Catheter splitting during advancement
Root Cause Attribution (n=38)
| Root Cause | Count | % |
|---|---|---|
| User error | 13 | 34% |
| Manufacturing | 8 | 21% |
| Design | 7 | 18% |
| Unknown | 6 | 16% |
| Environmental | 4 | 11% |
User error blamed (39%) roughly equals user error justified (39%). We do NOT see the blame-shifting pattern here that appears in other device categories. The n=38 sample is too small to be definitive.
BD Recall History
Three Class II recalls in our enforcement database -- all packaging issues, not device safety:
| Date | Issue |
|---|---|
| March 2020 | PowerGlide ST kit missing lidocaine (655 units) |
| Sept 2020 | PowerMidline kit missing stylet/T-lock assembly |
| Aug 2014 | Saline flush syringe in PowerGlide kits with open seals |
No safety recalls on the catheter itself despite consistent mechanical failure signals. This gap between MAUDE signal and enforcement action is worth monitoring.
BD Strengths & Weaknesses
Why BD wins today: Scale, distribution, GPO contracts, training infrastructure, inertia ("we've always used BD").
Where BD is vulnerable: 77% injury rate on PowerGlide Pro is rate-based and defensible regardless of volume. 90% mechanical failure rate points to design, not manufacturing. Same failure mode across multiple facilities -- that's not user error.
Sample Size Caveat
These sample sizes are small (n=13-40 per product). The injury rate pattern is consistent across PowerGlide products, which increases confidence, but individual product rates could shift with more data. Device linkage at 18.9% overall.
#2: ICU Medical PowerWand (~15% Share)
Formerly Smiths Medical. The #2 competitor and the product most likely to be on the shelf next to PowerGlide.
Product Profile
| Spec | Value |
|---|---|
| Insertion | Accelerated Seldinger Technique (AST) -- still guidewire-based |
| Sizes | 4 Fr and 5 Fr; 6 cm and 8 cm lengths |
| Power injectable | 300 psi / 5 ml/sec |
| Flow rates | 130 ml/min (4 Fr), 160 ml/min (5 Fr) gravity |
| Max dwell | 29 days |
| Material | CHRONOFLEX C with BIOGUARD Technology |
The BIOGUARD Story
ICU Medical's pitch is infection prevention, not insertion simplicity. BIOGUARD is an antimicrobial material that:
- Inhibits bacterial attachment (in vitro studies)
- Reduces thrombus formation (in vivo studies)
- Multiple independent studies show BSI reduction when combined with clinical protocols
This is a real differentiator -- but it addresses a different problem than Stiletto solves. BIOGUARD prevents infection after insertion. Stiletto prevents mechanical failure during insertion.
MAUDE Profile
Zero device-linked events in our database. One narrative mention across 2.48M events. This tells us nothing about safety -- PowerWand has meaningful market share but our device linkage (18.9%) likely doesn't capture it.
Competitive Positioning
Against BD: PowerWand competes on infection prevention. "Same insertion technique, better material."
Against Stiletto: PowerWand still uses a guidewire. It inherits the same mechanical failure mode risk as PowerGlide, even if the coating reduces infection. These are different value propositions solving different problems.
In a sales conversation: If the prospect uses PowerWand, don't attack the antimicrobial story -- it's defensible. Focus on the insertion mechanism: "BIOGUARD reduces infection after placement. SlipStream eliminates the mechanical failure that happens during placement. Both matter."
#3: Teleflex Arrow Midline (~10% Share)
Teleflex is primarily a CVC and PICC company. Their midline is a line extension, not their flagship.
Product Profile
| Spec | Value |
|---|---|
| Insertion | Modified Seldinger -- guidewire-based |
| Sizes | 4.5 Fr and 5.5 Fr |
| Power injectable | 5 ml/sec through distal lumen |
| Antimicrobial | Arrowg+ard Blue Advance (99.99% colonization reduction, 29 days) |
MAUDE Profile
| Metric | Value |
|---|---|
| Arrow Midline events | 9 |
| Injuries | 7 |
| Injury rate | 78% (n=9, too small) |
| Failure modes (extracted) | n=2 only: 1 guidewire tip separation, 1 material |
Nine events is not enough to draw conclusions. The 78% injury rate echoes the PowerGlide pattern, but n=9 is anecdotal, not statistical.
Competitive Positioning
Against BD: Arrow competes on antimicrobial coating (Arrowg+ard Blue). Similar to PowerWand's pitch.
Against Stiletto: Same guidewire-based insertion. Same category of mechanical failure risk. Teleflex's midline is not a major competitive threat in head-to-head situations -- they're more likely to lose to BD on distribution than to Stiletto on design.
Key fact: Teleflex's real strength is CVCs and PICCs (Arrow CVC 3-Lumen: 19 events, Arrow Ultraflex IAB: 18 events). Their midline is a secondary product line.
#4: AngioDynamics BioFlo (~8% Share)
The most technically interesting competitor. AngioDynamics competes on material science, not insertion mechanism.
Product Profile
| Spec | Value |
|---|---|
| Insertion | Guidewire-assisted |
| Technology | Endexo -- anti-thrombotic catheter surface |
| Power injectable | 325 psi (varies by size: 2-6 ml/sec) |
The Endexo Story
Endexo is a surface modification technology that integrates into the catheter material (not a coating that degrades). AngioDynamics' clinical claim: 94% less thrombus accumulation vs BD PowerGlide (measured by platelet count).
This is a strong clinical argument. Thrombus formation is the leading cause of catheter failure during dwell time. If Endexo works as claimed, it extends catheter life and reduces occlusion-related complications.
MAUDE Profile
| Metric | Value |
|---|---|
| BioFlo events (non-port) | 23 |
| Injuries | 16 |
| Injury rate | 70% (n=23) |
| Failure modes (extracted) | n=6: 67% mechanical, 17% sterility, 17% material |
BioFlo also shows a mechanical failure majority, but n=6 is too small to compare patterns. The 70% injury rate is in the same range as BD's midline products -- suggesting the guidewire insertion mechanism (which BioFlo also uses) may be the common factor.
Competitive Positioning
Against BD: "Better material science. Less thrombus. Longer catheter life." -- a compelling clinical argument.
Against Stiletto: BioFlo solves the dwell-time problem (thrombosis). Stiletto solves the insertion-time problem (mechanical failure). In a head-to-head, the question is which failure mode the facility cares about more.
The opening: If a facility is evaluating BioFlo, they're already willing to switch from BD. That's the hardest part. Position Stiletto as "solves a different problem, and it's the problem that causes the most dramatic adverse events (retained fragments, surgical retrievals)."
#5: Other Players
Cook Medical -- ~10% Share (Vascular Access, Not Midline)
Stents and interventional accessories. Minimal midline presence. Not a direct competitor.
Vygon -- ~8% Share (Europe)
Lifecath PICC and Nutricath lines. Minimal US MAUDE presence (<10 events). European-focused. Not a near-term US competitive threat.
The Guidewire Problem: Structural Insight
This is the sharpest insight from the data and the one that frames every competitive conversation.
Every guidewire-based midline inherits the same mechanical failure risk:
- Catheter pulled against sharp needle bevel during repositioning
- Guidewire kinks under torque
- Catheter material shears at stress concentration point
ICU Medical and Teleflex mitigate post-insertion risk with antimicrobial coatings. AngioDynamics mitigates dwell-time risk with anti-thrombotic surfaces. None of them address the insertion-time mechanical failure that drives the 90% failure mode in BD's data.
Stiletto eliminates the mechanism entirely. No guidewire = no guidewire failures. This isn't incremental improvement. It's a different engineering approach.
Head-to-Head Comparison
| Dimension | BD PowerGlide | ICU Medical PowerWand | Teleflex Arrow | AngioDynamics BioFlo | Stiletto |
|---|---|---|---|---|---|
| Guidewire | Yes | Yes | Yes | Yes | No |
| Insertion steps | 5 | 3-4 (AST) | 5 | 5 | 2 |
| Power injectable | Yes | Yes | Yes | Yes | Yes |
| Antimicrobial | No | BIOGUARD | Arrowg+ard | No | No |
| Anti-thrombotic | No | Partial | No | Endexo | No |
| MAUDE injury rate | 77% (n=26) | No data | 78% (n=9) | 70% (n=23) | No data |
| Mechanical failure % | 90% (n=90) | No data | n=2 | 67% (n=6) | No data |
| Market share | ~40% | ~15% | ~10% | ~8% | <5% |
| GPO penetration | Deep | Moderate | Moderate | Limited | Limited |
| Sales force | Large | Medium | Large (CVC focus) | Small | Small |
Why We Don't Compare Raw Event Counts
BD has ~40% share with hundreds of thousands of devices deployed. Comparing raw MAUDE event totals across products with different installed bases is comparing market share, not safety. Rates and patterns are the meaningful metrics.
The October 2025 PowerGlide Spike
Honest Assessment
This spike was clinical trial batch reporting, NOT a quality crisis. Do not use it as FUD.
| Month | PowerGlide Events | Injuries | Pattern |
|---|---|---|---|
| Nov 2024 - Sep 2025 | 1-2/month | <2/month | Baseline |
| October 2025 | 40 | 30 | 40x baseline |
| November 2025 | 1 | 0 | Back to baseline |
30 of 40 events reported on a single day (October 22, 2025). Two of four extracted summaries explicitly mention "clinical trial." November returns to baseline. This is batch reporting from a completed study, not a field quality crisis.
Signals to Watch
| Signal | What It Means | Current Status |
|---|---|---|
| BD recall on PowerGlide mechanism | Design flaw confirmed by FDA | No recall on catheter itself |
| ICU Medical PowerWand MAUDE events | First real safety signal for #2 player | Zero events linked |
| Hospital system switches from BD | Market movement | Isolated cases |
| AngioDynamics Endexo clinical data | Strengthens or weakens anti-thrombotic claim | Monitoring |
| New 510(k) entrants | Market fragmentation | Monitoring |
Strategic Takeaways
Every competitor uses a guidewire. Stiletto is the only midline that eliminates it. This is a structural differentiator, not a feature comparison.
Two innovation stories. Coating chemistry (ICU Medical, Teleflex, AngioDynamics) vs. engineering simplicity (Stiletto). The coatings address post-insertion complications. Stiletto addresses the insertion failure itself.
BD's vulnerability is rate-based. 77% injury rate and 90% mechanical failures are defensible claims regardless of market share. They describe what happens when an event occurs, not how many events exist.
PowerWand is the most relevant #2 competitor. Same insertion technique as BD but with an antimicrobial story. If a facility switches from BD to PowerWand, they've solved infection risk but not mechanical failure risk.
BioFlo is the most scientifically interesting competitor. Endexo (94% less thrombus vs PowerGlide) is a real clinical claim. If a facility is evaluating BioFlo, they're already willing to switch -- that's the hard part.
Acknowledge what you don't know. Small samples, 18.9% device linkage, zero MAUDE data on PowerWand and Stiletto. Compete on design logic and BD's documented patterns, not on claims about products with insufficient field data.
Data: FDA MAUDE via ScanPath ClickHouse. BD Power line: ~150 device-linked events, 90 with LLM extraction. Arrow Midline: 9 device-linked events. BioFlo: 23 non-port events. PowerWand: 0 device-linked events. Stiletto: 0 device-linked events. Device linkage at 18.9% overall. See Methodology for full data quality assessment.