Recall Z-2165-2008 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Boston Scientific Corporation
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.
| Date | Aug 26, 2008 (initiated May 1, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 24 Units |
| Distribution | International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.