Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04
FDA device recall Z-2165-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 24 Units
- Distribution
- International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.
- Date initiated
- 2007-05-01
- Date posted
- 2008-08-26
- Date terminated
- 2008-09-10
- Location
- Natick, MA
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