CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report

Extractor Pro RX Retrieval Balloon Catheter recalled

Boston Scientific is recalling Extractor Pro RX Retrieval Balloon Catheter, distributed nationwide in the US. The recall was initiated on 28 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesInstructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

Quantity recalled156 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2618-2025
FDA event ID: 97529
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Aug 2025
FDA classified: 23 Sep 2025
Reported: 1 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

28 Aug 2025	Recall initiated by company
23 Sep 2025	Classified by FDA	+26 days
1 Oct 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

Product as listed by the FDA

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Where it was distributed

US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.

Nationwide California Colorado Georgia Idaho Illinois Indiana Massachusetts Maine Michigan Mississippi North Carolina Ohio Oklahoma Pennsylvania South Dakota Tennessee Texas Virginia Washington

Questions about this recall

Is Extractor Pro RX Retrieval Balloon Catheter recalled?

Yes. Boston Scientific recalled Extractor Pro RX Retrieval Balloon Catheter on 28 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2618-2025.

Why was it recalled?

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

Which lots are affected?

Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

Where was it sold?

US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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