Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling 1,994 Chameleon PTA Balloon Dilation Catheter devices (8 mm x 40 mm, product numbers CH08-40-75GB and CH08-40-75US) distributed worldwide including the United States, Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China. The company received six complaint reports indicating that the balloon protector sleeve is difficult to remove from the catheter, requiring excessive force. If the balloon becomes damaged during sleeve removal and the catheter is used in a patient procedure, potential complications could include vessel perforation, foreign body lodged in the patient, embolism, risks requiring surgical intervention, or delays to necessary treatment.
The recall affects devices with specific lot and batch numbers identified in the recall notice. The record 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 firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
Reason for recall: The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy. Distribution: Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China. Quantity: 1,994 devices Lot/code info: UDI: 10884521812253, 07290016745047, 10884521812291 For CFN CH08-40-75US: GTIN Batch 07290016745047 21904374 07290016745047 21904432 07290016745047 22000673 07290016745047 22000709 07290016745047 22000817 07290016745047 22000880 07290016745047 22001030 07290016745047 22001061 07290016745047 22001191 07290016745047 22001310 07290016745047 22001417 07290016745047 22001448 07290016745047 22001728 07290016745047 22002086 07290016745047 22002088 10884521812253 22002498 07290016745047 22002583 10884521812253 22002603 07290016745047 22003037 07290016745047 22100003 07290016745047 22100321 07290016745047 22100322 07290016745047 22101089 07290016745047 22101090 10884521812291 22102189
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.