Catheter, Angioplasty, Peripheral, Transluminal

Brand Name: Finesse BTK Multicath

Potential for the balloon in the device to not meet burst specifications.

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,

Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

Medtronic NanoCross Elite PTA catheter,

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75

Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

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-

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.

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO.

Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.

Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.

Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire;

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Cordis POWERFLEX PRO PTA Dilatation Catheter

One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.