FDA (Devices) recall action 75785
The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.
Oscor, Inc. is recalling 45 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner may come out during insertion.
Oscor, Inc. is recalling 55 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.
Oscor, Inc. is recalling 110 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 30 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 61 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The product was distributed in the US and internationally.
Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 87 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 124 units of the Adelante Breezeway 10F sheath because a fragment of the inner liner detached during insertion. The product was distributed worldwide.
Oscor, Inc. is recalling 991 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.
Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found during insertion.
Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling specific lots of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 76 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 20 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 156 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 34 units of the Adelante Breezeway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 21 units of the Adelante Breezeway 8F sheath because a fragment of the inner liner detached during insertion. The product is distributed worldwide.
Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Oscor, Inc. is recalling 11 Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion.