FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
- Recall number
- Z-0021-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
- Status
- Open, Classified
- Initiated
- 2023-07-27
- Posted
- 2023-10-03
- Terminated
- not on file
- Reason
- Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
- Root cause
- Employee error
- Action
- Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.
- Quantity
- 828 units
- Distribution
- US Nationwide distribution in the state of Indiana.
- Lot, serial or model codes
- GTIN 08714729244349, Lot/Batch Numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596 ****letter has more lot numbers than spreadsheet*****
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28