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Boston Scientific Scimed Maverick 2 Monorail" PTCA… recallZ-2165-2008 · Boston Scientific Corporation · initiated May 1, 2007

Terminated All recalls posted in August 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.

Recall details

Recall number
Z-2165-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 1, 2007
Posted by the FDA
Aug 26, 2008
Recalling firm
Boston Scientific Corporation
Quantity
24 Units
Product code
LOX
FDA submissions
P860019
Distribution
International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.

Product description

Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Code information (models, lots, serial numbers)

Lot 9565194, Exp April 2010.

Other devices under the same FDA submission

105 devices cleared under P860019 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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