Arthrocare Corporation

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Electrosurgical, Cutting & Coagulation & AccessoriesGEI2,632
• Fastener, Fixation, Nondegradable, Soft TissueMBI765
• Accessories, ArthroscopicNBH315
• Suture, Nonabsorbable, Synthetic, PolyethyleneGAT174
• PasserHWQ153
• Screw, Fixation, BoneHWC113
• Product code KOGKOG72
• Pin, Fixation, SmoothHTY49
• ArthroscopeHRX43
• Orthopedic Manual Surgical InstrumentLXH35

Recent recalls

• 2016-04-05TerminatedPackage design/selection

  TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

  During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.

• 2016-01-08TerminatedUnder Investigation by firm

  Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.

  There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.

• 2015-07-18TerminatedNonconforming Material/Component

  EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

  Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

• 2011-10-14TerminatedPackaging process control

  ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

  ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

• 2011-04-12TerminatedProcess control

  ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

  During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.

• 2009-08-30TerminatedPackage design/selection

  ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA

  Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.

• 2008-09-19TerminatedPackaging

  ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

  Product is not secure in packaging, and movement may damage the product or render it non-sterile.

• 2008-09-16TerminatedPackaging process control

  ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures.

  Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.

• 2006-08-02TerminatedPackaging process control

  OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures.

  The product may lose sterility due to omission of the final pouch seal.

• 2006-06-27TerminatedPackaging process control

  ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085

  Potential loss of product sterility due to breach of pouch seal.