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,…
Bard Peripheral Vascular Inc · Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an oute…
Open FDA's page for this record- Cfres ID
- 212249
- Product res number
- Z-1244-2025
- Event date initiated
- 2025-02-05
- Event date posted
- 2025-03-05
- Recall status
- Open, Classified
- Res event number
- 96174
- Product code
- MCW
- Firm FEI number
- 2020394
- Recalling firm
- Bard Peripheral Vascular Inc
- Address 1
- 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy.
- Address 2
- Bldg 1
- City
- Tempe
- State
- AZ
- Postal code
- 85281-2438
- Additional info contact
- 480-303-2602
- Root cause description
- Under Investigation by firm
- Product quantity
- 15,755
- Product description
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
- Code info
Instructions for Use versions prior to ZE10895 revision C1 09/24. REF/UDI-DI/Lot(Expiration): 80236/07640142811855/230893(2025-12-15), 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), 231400(2026-07-14), 231414(2026-07-31), 231412(2026-06-30), 231413(2026-07-31), 231411(2026-08-03), 231521(2026-09-01), 231520(2026-07-31), 231522(2026-08-31), 231523(2026-09-01), 231524(2026-09-01), 231525(2026-09-01), 231715(2026-09-22), 231885(2026-09-22), 231884(2026-10-27), 240020(2026-11-22), 240396(2026-12-08), 240530(2027-01-10), 240531(2027-01-10), 240566(2027-01-10), 240568(2027-01-25), 240754(2027-02-06), 240769(2027-02-09), 240795(2027-03-04), 241074(2027-03-07), 241119(2027-03-21), 241190(2027-04-16), 241325(2027-04-16), 241328(2027-04-25), 241336(2027-04-29), 241464(2027-05-07), 241471(2027-05-27), 241553(2027-06-05), 242019(2027-06-28), 242023(2027-06-12), 242057(2027-06-20), 242056(2027-06-20), 242112(2027-06-26), 242160(2027-07-25), 242321(2027-07-08), 242493(2027-08-01), 242596(2027-09-20), 242693(2027-11-06); 80238/07640142811879/230895(2025-11-23), 240128(2026-05-31), 240276(2026-05-31), 240532(2026-05-31), 240658(2026-09-30), 241076(2026-09-30), 241330(2026-09-30), 241548(2026-09-30), 241768(2026-09-30), 241911(2026-09-30), 242117(2026-09-30), 242494(2026-09-30), 242521(2026-09-30), 242519(2026-05-31), 242520(2026-09-30); 80239/07640142811886/230896(2025-11-23), 231231(2026-06-13), 231410(2026-06-13), 231527(2026-08-31), 231883(2026-10-19), 232029(2026-08-31), 232028(2026-10-19), 240129(2026-11-30), 240278(2026-11-30), 240557(2027-01-22), 240746(2027-01-22), 240794(2027-02-28), 241077(2027-04-08), 241188(2027-04-08), 241462(2027-05-03), 241523(2027-05-03), 241767(2027-06-26), 241910(2027-06-26), 242159(2027-08-09), 242322(2027-09-10), 242518(2027-09-10), 242694(2027-10-25), 242695(2027-10-25)
- Reason for recall
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.
- Action
On 2/5/2025, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to customers informing them of the following: 1) In order to minimize risks of illness or injury, please review the updates to the eIFU in their entirety. The updated eIFU can be found on BD's website at https://www.bardpv.com/Rotarex-IFU.php 2) Firm recommends that end users review the updated on-line, on-demand training on the safe and effective use of the Rotarex Atherectomy System, reflecting the recent eIFU updates. The online education may be completed by registering on the BDLA Learning Management System https://academy.bd.com. 3) If possible, post this notice with the stored product as evidence of the updated eIFU. 4) Share this notification with all users within your facility network of the product to ensure they are also aware of the updated eIFU. This correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 5) Complete and return the response form via email to BDRC20@bd.com Report any complaints experienced with the use of this product to the firm's Regional Complaint Center: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am to 5:00pm CT Email: productcomplaints@bd.com For additional information regarding Advance Clinical Education and Training Programs, please email the Advance Team at bdpi.advance@bd.com Distributors were provided with a copy of the customer communication (correction notice) and asked to provide a copy to all customers on BD's behalf. If you have any questions, call 480-303-2602.
- Distribution pattern
US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK
- K numbers
- K172315, K211738, K242757
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Peripheral, Atherectomy
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.4875
- Device class
- 2
- K number
- K933238, K915238, K260244, K151145, K172315, K233483, K094036, K021096, K153460, K942457, K970233, K071350, K100462, K122916, K170059, K071432, K250723, K022640, K152275, K222837, K133399, K161361, K093918, K190634, K182341, K993816, K211738, K993648, K060016, K140944, K212351, K060904, K960970, K083489, K250385, K982363, K982657, K170792, K211518, K901206 +106 more
- Registration number
- 2134265, 2020394, 3000279201, 1724474, 3017896194, 2648045, 3007048256, 3032916632, 1000121056, 2124215, 3003708554, 3010173425, 3014254831, 2183870, 2183744, 2244478, 3007695959, 3008814558, 3006946276, 3000126629, 3008363989, 3002631703, 3004859241, 9616684, 1061124, 3010273872, 3006702495, 3010280625, 3015124694, 2024311, 3016257349, 3009756153, 3010041511, 2939520, 3011137372, 3003780911, 3003862657, 3016445722, 3007284006, 3020968442 +12 more
- FEI number
- 3000279201, 2020394, 2648045, 3017896194, 3007048256, 3032916632, 1000121056, 2124215, 1000512168, 3003708554, 3002807036, 3014254831, 3003094851, 2183870, 2183744, 3002806434, 3007695959, 3008814558, 3006946276, 3000126629, 3008363989, 3002631703, 3004859241, 3010273872, 3006702495, 3010280625, 3015124694, 2024311, 3016257349, 3009756153, 3010041511, 3002095335, 2939520, 3001451463, 3003780911, 3003862657, 3016445722, 3007284006, 3020968442, 3004742232 +12 more