Class I – The Withdrawn

DV-001 · 1974

contraception

The Dalkon Shield — A Faked IUD That Killed Seventeen and Wrote Device Law

death infection-sepsis infertility septic-abortion contraception obstetrics-gynecology 1970s 1980s

~3.5 yrs (Jan 1971 – Jun 1974 U.S. sales) · Withdrawn

DV-002 · 1986

cardiac surgery

The Björk-Shiley Convexo-Concave valve — a Welded Strut That Snapped and Killed Two-Thirds

mechanical-fracture sudden-death cardiac-surgery cardiology 1980s 1990s

~7 yrs (1979 US approval – 1986 withdrawal) · Recalled (Class I)

DV-003 · 2010

orthopedic implant

The DePuy ASR Hip — Metal Poisoning, a 2010 Recall, and $4 Billion

implant-failure metal-toxicity-metallosis revision-surgery orthopedic-surgery 2000s 2010s

~7 yrs (2003 launch – 24 Aug 2010 recall) · Recalled (Class I)

DV-004 · 2007

cardiac electrophysiology

The Sprint Fidelis Lead — the Thin Wire That Shocked, Failed, and Stayed Inside

death inappropriate-shock mechanical-fracture therapy-failure cardiac-electrophysiology cardiology 2000s 2010s

~3 yrs (Sep 2004 – Oct 15, 2007) · Recalled (Class I)

DV-005 · 2005

cardiac electrophysiology

The Guidant Ventak Prizm 2 DR — a Hidden Flaw, a Dead 21-Year-Old, a Guilty Plea

concealment death electrical-failure therapy-failure cardiac-electrophysiology cardiology 2000s 2010s

~3 yrs of concealment (Feb 2002 known → Jun 2005 recall) · Recalled (Class I)

DV-006 · 2011

cardiac electrophysiology

The St. Jude Riata Leads — Wires That Wore Through Their Own Insulation

death electrical-failure inappropriate-shock insulation-abrasion cardiac-electrophysiology cardiology 2000s 2010s

~9 yrs (sales 2001/2002 – Dec 2010; recalled 2011) · Recalled (Class I)

DV-007 · 1994

cardiac electrophysiology

The Telectronics Accufix — the Pacemaker Wire That Speared Six Hearts

cardiac-laceration death mechanical-fracture cardiac-electrophysiology cardiology 1990s

~6 yrs (c. 1988 – Nov 1994) · Recalled (Class I)

DV-008 · 2019

breast implants

The Allergan BIOCELL Implants — Textured Shells Tied to Cancer and 33 Deaths

cancer-bia-alcl death oncology plastic-surgery 2010s

~13 yrs (Nov 2006 U.S. approval – Jul 2019 recall) · Recalled (Class I)

DV-009 · 2010

cosmetic & reconstructive implants

The PIP breast implants — 300,000 Women Filled With Secret Industrial Silicone

fraud rupture-leak systemic-toxicity plastic-surgery 2000s 2010s

~9 yrs fraudulent fill (c.2001 – Mar 2010) · Recalled (Class I)

DV-010 · 2019

urogynecology

Transvaginal Mesh — 100,000 Lawsuits, $8 Billion, and a 2019 U.S. Ban

chronic-pain reoperation tissue-erosion obstetrics-gynecology urogynecology 2000s 2010s

~2002–2019 (transvaginal POP) · Reclassified

DV-011 · 2018

contraception

Essure — the Permanent Coils That Perforated Organs and Cost $1.6 Billion

chronic-pain migration perforation unintended-pregnancy contraception obstetrics-gynecology 2000s 2010s

~16 yrs (2002–2018) · Withdrawn

DV-012 · 2014

gynecologic surgery

The laparoscopic power morcellator — the Tool That Spread Hidden Uterine Cancer

cancer-dissemination-upstaging death gynecologic-surgery oncology 2010s

~21 yrs (1993 U.S. introduction – 2014 withdrawal) · Withdrawn

DV-013 · 2012

orthopedics

The Stryker Rejuvenate and ABG II — Hip Stems That Corroded for $1.4 Billion

corrosion metal-toxicity-metallosis revision-surgery orthopedic-surgery 2010s

~4 yrs (2008/2009 launch – Jul 2012 recall) · Recalled (Class I)

DV-014 · 2015

venous thromboembolism

The Bard Recovery IVC Filter — Struts That Broke Loose and Killed 27

concealment death mechanical-fracture migration-embolization interventional-radiology vascular-medicine 2000s 2010s

~2.5 yrs (Recovery, mid-2003 – 2005 before replacement) · Withdrawn

DV-015 · 1986

radiation oncology

The Therac-25 — the Software Bug That Radiated Patients to Death

death radiation-overdose software-defect medical-physics radiation-oncology 1980s

~1982–1987 (accidents Jun 1985 – Jan 1987) · Recalled (Class I)

Implanted in millions. Recalled after the harm.