Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathol
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 41 units of the Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm with expiration dates between June 8th and July 22nd, 2021. The recall affects devices with material number H7493932800350 and specific lot numbers (25754545, 25852104, 2582106, 25856700) that were distributed nationwide, including in Maryland, New York, Michigan, Connecticut, South Dakota, and Georgia. The catheters are being recalled because incremental telescoping length markings near the proximal end of the catheter shaft can flake off during manipulation.
No patient harm has been reported to date. The most common potential consequence would be a prolonged procedure requiring catheter exchange, as the flaking would be observable before use in the patient's body. The most serious potential consequence would be embolization if flaking marks advance while flushing the catheter. According to the recall record, all recalled devices should be returned to Boston Scientific, though the source does not specify a detailed remedy process for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
Reason for recall: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific. Distribution: US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA. Quantity: 41 devices Lot/code info: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.