Z-1582-2022Class II

Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

Name: Z-1582-2022 Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Creator: Boston Scientific Corporation
Published: 2022-08-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-08-09 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 on 2022-08-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1582-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-09
Posted: 2022-08-25
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Product code: DQY Catheter, Percutaneous
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1582-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1582-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25

Product code DQY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)