Z-0852-2019Class II

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or...

Name: Z-0852-2019 Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or...
Creator: Boston Scientific Corporation
Published: 2018-12-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-12-19 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous... on 2018-12-19. FDA classified it as Class II and gives the reason as "A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0852-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-02-20
Terminated: 2020-06-09
Recalling firm: Boston Scientific Corporation
Product: 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).
Product code: DQX Wire, Guide, Catheter
Reason for recall: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Boston Scientific notified customers on about 12/19/2018 via "Urgent Medical Device Removal - Immediate Action Required" notice. Instructions included to immediately discontinue use of and segregate affected product, complete and return the Reply Verification Tracking Form to receive a RGA to return affected product, return all affected product, notify customers of the recall if product was further distributed.
Quantity in commerce: 49 units
Distribution: Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Product codes and lots: Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0852-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0852-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-20

Product code DQX

K122795Class IIStingray GuidewiresBridgepoint Medical / cleared 2012-11-08

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)