Reported Mar 12, 2025 · Ongoing
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:…
Bard Peripheral Vascular Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- Rotarex Atherectomy System and Instructions for Use
- BD SET RotarexS 6 F x 110 cm
- REF
80236S 6 F x 135 cm
- REF
80237S 8 F x 85 cm
- REF
80238S 8 F x 110 cm
- REF80239
- Lot codes and dates
4 of 4 products · 101 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lot (Expiration) 80236076401428118552308932025-12-152311002026-06-092311722026-06-092311712026-06-092315262026-08-212318752026-08-212400182026-11-222400172026-11-222403752027-01-182405672027-01-182410752024-05-222413352024-06-192415502024-07-192417772024-08-192426912024-12-13
80237076401428118622308972026-04-112308982026-04-112310332026-05-312311012026-06-132311702026-06-132312292026-07-072314002026-07-142314142026-07-312314122026-06-302314132026-07-312314112026-08-032315212026-09-012315202026-07-312315222026-08-312315232026-09-012315242026-09-012315252026-09-012317152026-09-222318852026-09-222318842026-10-272400202026-11-222403962026-12-082405302027-01-102405312027-01-102405662027-01-102405682027-01-252407542027-02-062407692027-02-092407952027-03-042410742027-03-072411192027-03-212411902027-04-162413252027-04-162413282027-04-252413362027-04-292414642027-05-072414712027-05-272415532027-06-052420192027-06-282420232027-06-122420572027-06-202420562027-06-202421122027-06-262421602027-07-252423212027-07-082424932027-08-012425962027-09-202426932027-11-06
80238076401428118792308952025-11-232401282026-05-312402762026-05-312405322026-05-312406582026-09-302410762026-09-302413302026-09-302415482026-09-302417682026-09-302419112026-09-302421172026-09-302424942026-09-302425212026-09-302425192026-05-312425202026-09-30
80239076401428118862308962025-11-232312312026-06-132314102026-06-132315272026-08-312318832026-10-192320292026-08-312320282026-10-192401292026-11-302402782026-11-302405572027-01-222407462027-01-222407942027-02-282410772027-04-082411882027-04-082414622027-05-032415232027-05-032417672027-06-262419102027-06-262421592027-08-092423222027-09-102425182027-09-102426942027-10-252426952027-10-25
- Amount recalled
- 15,755
Where it was sold
Why it was recalled
Stop using this product now
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Using this product could cause serious injury, illness or death — stop using it now.
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