MaxZeroRecalls & reported problems across all models

We found 47 models of MaxZero by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 2,377 adverse event reports in the FDA's MAUDE database, received between May 8, 2018 and Sep 30, 2026 — classified as 3 deaths, 86 injuries, 2,288 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (804 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MaxZero problems

MaxZero models

47 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MaxZero MZ1000-07

  Set, administration, intravascular
  622 reports
• MaxZero MZ1000

  Set, administration, intravascular
  379 reports
• MaxZero MZ5307

  Set, administration, intravascular
  134 reports
• MaxZero MZ9226

  Set, administration, intravascular
  130 reports
• MaxZero MZ9266

  Set, administration, intravascular
  1 death130 reports
• MaxZero MZ9270

  Set, administration, intravascular
  123 reports
• MaxZero MZ5303

  Set, administration, intravascular
  121 reports
• MaxZero MZ5304

  Set, administration, intravascular
  1 death94 reports
• MaxZero MZ9267

  Set, administration, intravascular
  60 reports
• MaxZero MZ5302

  Set, administration, intravascular
  57 reports
• MaxZero MZ9283

  Set, administration, intravascular
  54 reports
• MaxZero MZ5309

  Set, administration, intravascular
  53 reports
• MaxZero MZ9281

  Set, administration, intravascular
  51 reports
• MaxZero MZ5310

  Set, administration, intravascular
  46 reports
• MaxZero MZ9265

  Set, administration, intravascular
  39 reports
• MaxZero MZ5301

  Set, administration, intravascular
  30 reports
• MaxZero MZ9275

  Set, administration, intravascular
  25 reports
• MaxZero MZ9277

  Set, administration, intravascular
  25 reports
• MaxZero MZXT9001

  Set, administration, intravascular
  1 death25 reports
• MaxZero MZ9273

  Set, administration, intravascular
  21 reports
• MaxZero MZ9271

  Set, administration, intravascular
  17 reports
• MaxZero MZ5305

  Set, administration, intravascular
  14 reports
• MaxZero MZX5305

  Set, administration, intravascular
  13 reports
• MaxZero MZ9279

  Set, administration, intravascular
  12 reports
• MaxZero MZX5306

  Set, administration, intravascular
  12 reports
• MaxZero MZ9325

  Set, administration, intravascular
  11 reports
• MaxZero MZXT5307

  Set, administration, intravascular
  11 reports
• MaxZero MZ5313

  Set, administration, intravascular
  10 reports
• MaxZero MZ9313

  Set, administration, intravascular
  8 reports
• MaxZero MZ9294

  Set, administration, intravascular
  7 reports
• MaxZero MZ9292

  Set, administration, intravascular
  6 reports
• MaxZero MZXT5306

  Set, administration, intravascular
  5 reports
• MaxZero MZ5316

  Set, administration, intravascular
  5 reports
• MaxZero MZ5306

  Set, administration, intravascular
  3 reports
• MaxZero MZ9289

  Set, administration, intravascular
  3 reports
• MaxZero MZ5308

  Set, administration, intravascular
  2 reports
• MaxZero MZ9274

  Set, administration, intravascular
  2 reports
• MaxZero MZ9278

  Set, administration, intravascular
  2 reports
• MaxZero MZ9276

  Set, administration, intravascular
  2 reports
• MaxZero MZ8002

  Set, administration, intravascular
  2 reports
• MaxZero MZ9326

  Set, administration, intravascular
  2 reports
• MaxZero MZ9327

  Set, administration, intravascular
  2 reports
• MaxZero MZ9329

  Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 reports
• MaxZero MZT1003

  Set, administration, intravascular
  2 reports
• MaxZero MZ9290

  Set, administration, intravascular
  1 report
• MaxZero MZ9295

  Set, administration, intravascular
  1 report
• MaxZero MZ9324

  Set, administration, intravascular
  1 report

Recent MaxZero adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  The collar on MaxZero Microbore extension set syringe tubing broke off necessitating IV tubing set replacement. No harm to patient. Broken set discarded at time of event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945377 ↗
• MalfunctionSep 29, 2026Backflow; Fluid/Blood Leak; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935055 ↗
• MalfunctionSep 28, 2026Contamination

  Additional information:The feedback indicates that the residue was discovered inside the MaxZero housing on 7 Sept; however, it is unclear when the affected MZ1000 was first used; please confirm which date the MZ1000 was used from: - The hospital policy regarding the maximum interval between MaxZero replacements is to replace them at the same time as the IV set (at least once every week); however, since there are no records indicating whether this was properly followed in this case, it is unclear (it is possible that the MaxZero was never replaced after the PICC was inserted).Please clarify why the user believes that the MZ1000 is the cause of the observed residue:-We believe the issue stems from improper use¿possibly because the replacement was not performed correctly¿but we also believe that the Max Zero itself is designed in such a way that solution tends to remain even when the pulsed flash is performed correctly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913800 ↗
• MalfunctionSep 25, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905595 ↗
• MalfunctionSep 24, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890863 ↗
• MalfunctionSep 24, 2026Blocked Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890861 ↗
• MalfunctionSep 24, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887545 ↗
• MalfunctionSep 24, 2026Separation Problem

  It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876674 ↗
• MalfunctionSep 24, 2026Separation Problem

  It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876672 ↗
• MalfunctionSep 24, 2026Separation Problem

  It was reported that BD maxzero needless connector was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that the connector came apart and ,sprayed clinician in face, this happened in CT. This has been an ongoing issue along with CT other departments within the facility also are reporting this.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876671 ↗
• MalfunctionSep 23, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873027 ↗
• MalfunctionSep 23, 2026Complete Blockage

  It was reported, Maxzero, Unable to flush, during use. The following was provided by the initial reporter: Contaminated with chemical solution (unknown). According to the customer report an exchange was made on (b)(6), but when tried to flush the solution, it wouldn't flow during use.additional information:Could you please check the lot number? It is unknown.Was the defect observed during priming or during infusion? If during infusion, how much time had elapsed? We have not checked the details.Could you please check the manufacturer name and model number of the product connected to the MaxZero? Terumo (for the IV line).Could you please check the set for visible damage such as cracks, burrs, or piston deformation? There appears to be no damage, but please check it just in case.Could you please check what medication was being infused when the incident occurred? Unknown.Did the patient suffer any harm? Confirmed that there was no harm.Was the infusion volume insufficient? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868466 ↗
• MalfunctionSep 23, 2026Leak/Splash; Connection Problem

  It was reported, Maxzero, connection issues, causing leak.The following was provided by the initial reporter: During the procedure to insert an IV cannula on (b)(6) 2026, the nurse connected a clear, cannula-free connector to the patient. The connector did not lock securely, causing fluid leakage. The nurse immediately replaced it with a new clear, cannula-free connector.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868130 ↗
• MalfunctionSep 22, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860021 ↗
• MalfunctionSep 22, 2026Disconnection; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859134 ↗

Other BD Switzerland Sàrl products

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