The latest headlines across every section, pulled from official and open-access sources.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 288 units
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 13 units
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 17 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 8 units
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. — Stryker Neurovascular · Class II · Ongoing · 44,937
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient… — Intuitive Surgical, Inc. · Class II · Ongoing · 454
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 590 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
There is the potential for leakage along the drug pathway from the pump through the end of the catheter. — Boston Scientific Corporation · Class II · Completed · 1 device
Software anomaly that causes a false display of error code 5018. — IPG Medical Corporation · Class II · Ongoing · 198 units
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. — Zimmer, Inc. · Class II · Ongoing · 12
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 3 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 227 units
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation. — PFM MEDICAL INC. · Class II · Ongoing · 32
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113, 843 kits
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. — Medline Industries, LP · Class I · Ongoing · 503 units
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A