Z-1210-2010

Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404)...

Name: Z-1210-2010 Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404)...
Creator: Boston Scientific Corporation
Published: 2010-02-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-02-18 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620... on 2010-02-18. The reason FDA records is "Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1210-2010
Status: Terminated
Initiated: 2010-02-18
Posted: 2010-03-25
Terminated: 2011-12-10
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the catheter packaging (i.e. outer pouch side seal) of the affected products may be compromised. An undetected breach in sterility of the outer pouch may lead to contami
Root cause tag: packaging
FDA root cause: Packaging
Action: Two "URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED" letters dated February 17, 2010 and February 18, 2010 were sent to the customers. The letters described the Action Description, Affected Product and Recall Instructions. The customers should immediately discontinue use of and remove all affected recalled product from your inventory, segregate the product in a secure location for return to Boston Scientific, complete and return the enclosed Account Reply Verification Tracking Form (even if you do not have any product to return) -fax to: Customer Service Call Center (866) 213-1806, and package/ship the recalled product per instructions. Your local sales Representative can answer any questions that you may have regarding this Recall Removal. If you have any question, please contact (763) 494-7971.
Quantity in commerce: 99
Distribution: Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.
Product codes and lots: 12935858, 12935557, 12934317, 12934318, 12934319, 12934480

Product code FGE

K963397Class IIUltra-Thin Diamond Balloon Dilatation CatheterBoston Scientific Corp / cleared 1996-11-25

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)