Events

Rappel de Device Recall Boston Scientific, Small Peripheral Cutting BalloonTM

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65919
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2137-2013
  • Date de mise en oeuvre de l'événement
    2013-07-31
  • Date de publication de l'événement
    2013-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120866
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, angioplasty, peripheral, transluminal - Product Code LIT
  • Cause
    Boston scientific is initiating a recall removal of the 4.0mm x 15mm size of small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation devices and flextome cutting balloon (monorail and over-the-wire) microsurgical dilation devices. boston scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic.
  • Action
    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 30, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised that further distribution or use of the product should cease immediately, and to segregate the product and return it to Boston Scientific. Consignees were asked to complete and return the "Recall Removal Reply Verification Tracking Form". For questions consignees were instructed to contact their local Sales Representative. For questions regarding this recall call 763-494-2042.

Device

Device Recall Boston Scientific, Small Peripheral Cutting BalloonTM
  • Modèle / numéro de série
    UPN # 001BPM4015140F0, Catalogue #BPM4015140F.  Lot#'s 15778169, 15735527, 15774378, 15788826, 15812347, 15824636, 15825277, 15836626, 15873338, 15891705, 15931291, 15945240, 16057260.  UPN# M001PCBM4015140F0, Catalogue #PCBM4015140F, Lot #15756145.   UPN # M001PCBO4015140F0, Catalogue #PCBO4015140F,  Lot #'s 15688199, 15992736, 16066536, 16141255.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
  • Description du dispositif
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: || The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. || 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. || 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA