Angiodynamics, Inc.
37 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Angiodynamics, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-03-27FDA-DeviceClass IIMINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- 2024-03-27FDA-DeviceClass IIMINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- 2024-03-27FDA-DeviceClass IIMINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- 2024-03-27FDA-DeviceClass IIMINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- 2024-03-27FDA-DeviceClass IIMINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- 2024-02-14FDA-DeviceClass IIPulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- 2023-04-19FDA-DeviceClass IINanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
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