Z-0410-06

The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4...

Name: Z-0410-06 The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4...
Creator: Boston Scientific Corporation
Published: 2005-12-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-12-07 / Terminated

FDA source

Boston Scientific Corporation began a recall of The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally... on 2005-12-07. The reason FDA records is "The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0410-06
Status: Terminated
Initiated: 2005-12-07
Posted: 2006-02-01
Terminated: 2007-08-10
Recalling firm: Boston Scientific Corporation
Product: The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
FDA root cause: Other
Action: All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.
Quantity in commerce: individual qty in US:376, Worldwide distribution pending.
Distribution: Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey
Product codes and lots: Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554

Product code LIT

K052038Class IIPeripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation / cleared 2005-08-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)