Recall Z-2166-2008 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Boston Scientific Corporation
Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene oxide gas Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-2035 Use before 20
| Date | Aug 26, 2008 (initiated Nov 1, 2005) |
| Status | Terminated |
| Reason | Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label. |
| Root cause | Packaging process control |
| Action | Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned. |
| Quantity | 67 Units |
| Distribution | International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.