Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation recalled 184 Guider Softip XF guide catheters (model 40XF/8FR/90CM) that were distributed with an incorrect tip curve shape. The affected devices were shipped with an MPXF tip curve instead of the specified 40XF tip curve shape. The impacted products were distributed internationally to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, with no distribution to the United States.
The recalled devices include those with UDI/DI 08714729202486 and either Lot/Batch 27339850 (Use By 2021-05-18) or Lot/Batch 29308869 (Use By 4/27/2025). The source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Reason for recall: The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. Distribution: International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution. Quantity: 184 devices (UPDATED) Lot/code info: UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.