The Recall Desk
CriticalFDA (Devices)·Z-1244-2025·Announced 2025-03-12

Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk

Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device recall. The catheter presents a serious risk of helix fracture or breakage, which could cause vessel injury and severe bleeding.

Plain-English summary

The Rotarex Atherectomy System is an atherectomy catheter used in vascular procedures. The system is composed of an outer cylinder connected to a rotating helix. The recall concerns the potential for the helix to fracture or break during use.

If the helix breaks, the broken fragment could remain in the blood vessel, requiring surgical or interventional retrieval. A helix fracture could injure the vessel wall, resulting in severe bleeding.

The recall affects approximately 15,755 units distributed nationwide across the United States and Puerto Rico. The manufacturer is addressing this issue by distributing updated instructions for use (Revision C1, dated September 2024) that clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage.

The recalled product

Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Atherectomy Catheter
Hazard
  • catheter-breakage
  • helix-fracture
  • vessel-injury
  • bleeding

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 231100(2026-06-09)
  • 231172(2026-06-09)
  • 231171(2026-06-09)
  • 231526(2026-08-21)
  • 231875(2026-08-21)
  • 240018(2026-11-22)
  • 240017(2026-11-22)
  • 240375(2027-01-18)
  • 240567(2027-01-18)
  • 241075(2024-05-22)
  • 241335(2024-06-19)
  • 241550(2024-07-19)
  • 241777(2024-08-19)
  • 242691(2024-12-13)
  • 80237/07640142811862/230897(2026-04-11)
  • 230898(2026-04-11)
  • 231033(2026-05-31)
  • 231101(2026-06-13)
  • 231170(2026-06-13)
  • 231229(2026-07-07)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category