FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- Recall number
- Z-1582-2022
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- Status
- Open, Classified
- Initiated
- 2022-08-09
- Posted
- 2022-08-25
- Terminated
- not on file
- Reason
- The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
- Root cause
- Process control
- Action
- Stryker notified its consignees by issuing an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice on 8/9/2022 by courier. The notice described the problem and the hazard, and requested the consignee take the following actions: "Required Actions 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. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Return the completed form to your local Stryker Contact. 9. Product Return Information will be provided to you by your designated Sales Representative." UPDATE: On/about 2/13/2023, the amended letter was issued. It identified the lot number (which was in addition to the lot number in the initial recall) and provided the same instructions as were contained in the original notice issued 8/9/2022.
- Quantity
- 184 devices (UPDATED)
- Distribution
- International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
- Lot, serial or model codes
- UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.
- 510(k) numbers
- ["K010853","K980453"]
- 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