Z-0852-2019 Class II Terminated
FDA device recall Z-0852-2019 was initiated by Boston Scientific Corporation on Dec 19, 2018 and is designated Class II. Reason for recall: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. The recall status is terminated (terminated Jun 9, 2020). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 19, 2018
- Termination Date
- Jun 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Reason for Recall
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Distribution Pattern
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Code Information
Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0852-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026