Guider Softip XF recallZ-1582-2022 · Boston Scientific Corporation · initiated Aug 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1582-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 9, 2022
- Posted by the FDA
- Aug 25, 2022
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 184 devices (UPDATED)
- Product code
- DQY
- FDA submissions
- K980453, K010853
- 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.
Product description
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Code information (models, lots, serial numbers)
UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Guider Softip™ XF H965100440Boston Scientific Corporation · CATHETER, PERCUTANEOUS2 recalls2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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